Sorry, no earthshaking developments in the antidepressant world in 2003, but here are some developments that you’ll find useful in your practice.
Coming soon. Symbiax. Or so say the ads, indicating that it is on the verge of FDA approval. Brought to you by Eli Lilly, it is a combination of Prozac and Zyprexa. The word on the street is that it will be approved for bipolar depression. It’s an updated version of “Triavyl”, a combination of Trilafon and Elavil that is being marketed and consumed by many grateful patients to this very day.
Serzone is getting an increasingly harsh reception around the world. Since its approval in the United States in 1994, it has been linked to 55 cases of liver failure, including 20 deaths. In January 2003, Bristol Myers Squibb voluntarily withdrew the drug from the entire European market, and in November Canadian regulators kicked it out of town. Serzone is now only available in the U.S. and Australia, but probably not for long: Public Citizen, the consumer group founded by Ralph Nader, has sent a petition to the FDA calling for removal of Serzone from the U.S. market ASAP.
Provigil is gaining popularity among psychiatrists, both as a treatment for residual symptoms of depression and for ADHD. The first placebo-controlled study for treatment of depression was just published (DeBattista et al, J Clin Psychiatry 2003;64:1057-1064). Enrolled patients were partial responders to antidepressants, and were randomly assigned to 6 weeks of either Provigil 100-400 mg QD, or placebo. The Provigil patients were less sleepy and fatigued than placebo patients by week two, but placebo caught up to Provigil by week 6. There were no differences between the groups in overall depression scores. Bottom line is that, yes, Provigil wakes sleepy patients up quickly, but after a few weeks it may have little additive effect. Caveat: The FDA has not approved Provigil for use in anything other than narcolepsy. However, in November an advisory panel recommended that it should be approved for sleepiness associated with both sleep apnea and shift work.
Paxil CR treats the hot flashes of menopause pretty well. A recent study (Stearns et al., JAMA. 2003;289:2827- 2834) showed that hot flash composite scores were reduced by 62% in those receiving 12.5 mg/d of Paxil CR, 64% in those receiving 25 mg QD, and 39% in the placebo group. There is now something of a hot flash war among newer antidepressants: Prozac leads to a 50% reduction over 4 weeks at 20 mg/d, and Effexor XR causes a 61% reduction over 4 weeks at 75 mg QD and 150 mg QD. Estrogen, the gold standard, typically reduces them by 80%.
Wellbutrin XL was approved for depression in August of 2003. It can be dosed once a day; it comes in 150 mg and 300 mg tablets, and the maximum recommended dose is 450 mg QD. You can switch directly from either IR or SR Wellbutrin to the same dosage of XL. All the usual seizure cautions apply-don’t give it to patients with a history of seizures or eating disorders, and don’t go higher than 450 mg unless you like living dangerously. You’ll notice that GlaxoSmithKline, the manufacturer, is saturating the airwaves with direct to consumer ads for XL. The reason for this push, of course, is that Eon Pharmaceuticals announced in November that it had received FDA approval for a generic version of Wellbutrin SR. GSK is suing Eon as a delaying tactic, but that won’t prevent generic SR from reaching a pharmacy near you.
Remeron for Sleep Apnea. Now you can offer your sleep apnea patients something besides sympathy and support. Dr. David Carley, a sleep researcher at the University of Illinois Chicago, reported the results of a study of Remeron given to 12 patients with sleep apnea. A crossover study, the patients were divided into three groups of 4, and each group tried each of the following treatments on alternate weeks: placebo, Remeron 4.5 mg QD, and Remeron 15 Q D. The 15 mg dose beat placebo in reducing episodes of apnea and in reducing sleep disruptions. This was presented at the 2003 meeting of the Associated Professional Sleep Societies. And yes, it was funded by Organon.
Substance P blocker doesn’t work. Merck & Co. announced on Nov 12 that aprepitant, its Substance P Antagonist (SPA), had failed antidepressant trials and would no longer be developed as a potential antidepressant. Merck isn’t the only one who is disappointed. Psychiatrists throughout the world were hoping for some relief from the barrage of copycat SSRIs and SNRIs that have been flooding the market.
Generic Watch: Fluoxetine (generic of Prozac) is getting cheaper and cheaper, but tell your patients it pays to shop around. Some pharmacies make big bucks on marking up generics. North of Boston, the price for one month of fluoxetine (20 mg QD) varies from $25 to $50….Paroxetine has gone generic, in case you hadn’t heard. But it’s not much of a bargain at $75-$90 per month (20 mg QD), only $20 cheaper than Paxil….And don’t forget about bupropion IR (the generic version of Wellbutrin IR), 60% cheaper than Wellbutrin XL and every nanometer the same molecule.
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